Head and Neck NeoplasmsNCT06840639
The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.
An observational study of Head and Neck Neoplasms and Radiotherapy; Complications, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Study the risk of complications after dental extractions in patients recieving radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Neoplasms, Radiotherapy; Complications, Extracting Own Teeth
- What is being tested?
- Dentoalveolar surgery
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients receiving radiotherapy for malignant diagnosis (oral and oropharyngeal cancers)
Who may be able to join
- Malignant diagnosis
- radiotherapy pre or postoperative
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Study the risk of complications after dental extractions in patients recieving radiotherapy.
Read the detailed description
Dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. There are contradictory results in the literature regarding the importance timing and magnitude of extractions. It is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. Patients were extracted from the ARTSCAN register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. The aim is to evaluate which diagnoses are more prone to develop complications after extraction. If there is a relationship between occurrence of complication and magnitude of dental pathology.
- Being tested
- Dentoalveolar surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dentoalveolar surgeryProcedure or surgery
Surgery to extract teeth
| Study group | Role | What they receive |
|---|---|---|
| Dental extractions with complications | patients recieving dental extractions and developing osteoradionecrosis Receives: Procedure: Dentoalveolar surgery | |
| Dental extractions without complications | patients recieving dental extractions and not developing osteoradionecrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does dental extractions increase the risk for complications such as osteoradionecrosis?
Type of complication when extracting teeth in conjunction with radiotherapy.
Measured: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Does dental pathology in extracted teeth correlate with development of osteoradionecrosis?
Are any specific dental pathology more prone to develop complications than others?
Measured: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Fransson, Msc, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840639
- Sponsor's protocol ID
- LundUH2
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.
- ClinicalTrials.gov ID
- NCT06840639
- Acronym / sponsor ID
- LundUH2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the risk of complications after dental extractions in patients recieving radiotherapy.
Detailed description
Dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. There are contradictory results in the literature regarding the importance timing and magnitude of extractions. It is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. Patients were extracted from the ARTSCAN register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. The aim is to evaluate which diagnoses are more prone to develop complications after extraction. If there is a relationship between occurrence of complication and magnitude of dental pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental extractions with complications | – | Procedure: Dentoalveolar surgerypatients recieving dental extractions and developing osteoradionecrosis |
| Dental extractions without complications | – | –patients recieving dental extractions and not developing osteoradionecrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving radiotherapy for malignant diagnosis (oral and oropharyngeal cancers)
Key inclusion criteria (2 listed)
- Malignant diagnosis
- radiotherapy pre or postoperative
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dentoalveolar surgerySurgery to extract teeth | Procedure or surgery | Dental extractions with complications |
Primary outcome
Does dental extractions increase the risk for complications such as osteoradionecrosis?
Time frame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Type of complication when extracting teeth in conjunction with radiotherapy.
Does dental pathology in extracted teeth correlate with development of osteoradionecrosis?
Time frame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Are any specific dental pathology more prone to develop complications than others?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Fransson, Msc principal investigator
Lund University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Radiotherapy; Complications, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does dental extractions increase the risk for complications such as osteoradionecrosis? (time frame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.